Recall Z-0407-2014 ยท JDS Nail, Fixation, Bone
Synthes USA HQ, Inc.
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
| Date | Nov 27, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. |
| Root cause | Pending |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. |
| Quantity | 14 |
| Distribution | Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033071 | SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM Synthes (Usa), Nov 5, 2003 |